DAILY ECLIPSE SPF 30 UNTINTED- titanium dioxide, zinc oxide cream

Daily Eclipse SPF 30 Untinted by

Drug Labeling and Warnings

Daily Eclipse SPF 30 Untinted by is a Otc medication manufactured, distributed, or labeled by DermaMed Solutions, LLC, Trilogy Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Titanium Dioxide, 7.5%

Zinc Oxide, 12%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

Uses

Helps prevent sunburn

DOSAGE & ADMINISTRATION

Directions

• Apply liberally 15 minutes before sun exposure.
• Children under six months: Ask a doctor.
• Reapply at least every 2 hours.
• Use a water resistant sunscreen if swimming or sweating
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 am - 2 pm
• Wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT

Inactive ingredients

Aqua (water), Capric / Caprylic Triglycerides, Cetearyl Olivate and Sorbitan Olivate, Cimethicone (and) Dimethicone, Glycerin, Cyclopentasiloxane, Aloe Barbadensis, Vaccinium Vitis-idaea Fruit Extract (Lingostern), L- Ascorbic Acid, Camellia Sinensis (Green Tea) Leaf Extract, Phenoxyethanol, Ethylhexylglycerin, Fragrance (Natural)

WARNINGS

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask doctor if rash occurs

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DAILY ECLIPSE SPF 30 UNTINTED 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72492-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	6 g  in 50 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	3.75 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
FERRIC OXIDE RED (UNII: 1K09F3G675)
WATER (UNII: 059QF0KO0R)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
VACCINIUM VITIS-IDAEA FRUIT OIL (UNII: 16Y54799WZ)
TRICAPRIN (UNII: O1PB8EU98M)
DIMETHICONE (UNII: 92RU3N3Y1O)
GLYCERIN (UNII: PDC6A3C0OX)
ALOE VERA WHOLE (UNII: KIZ4X2EHYX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72492-001-01	50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/31/2018
2	NDC: 72492-001-02	118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/31/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/31/2018

Labeler - DermaMed Solutions, LLC (968830559)

Establishment
Name	Address	ID/FEI	Business Operations
Trilogy Laboratories, LLC		079652958	manufacture(72492-001)